1. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017 Subject(s): Clinical Trials as Topic -- standardsHuman Experimentation -- standardsInformed Consent -- standardsEthics Committees, ResearchEthics, ResearchInformed Consent -- ethicsResearch SubjectsRiskHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
